Albiglutide Thorough ECG Study in Healthy Volunteers

NCT01406262 | Completed Phase 1 DMC

• 1 other identifier: 107085
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to investigate the effect of treatment with albiglutide on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

Conditions

Diabetes Mellitus, Type 2

Keywords

albiglutide; QT interval; cardiac repolarization; ECG study

Outcome Measures

Primary Outcomes (1)

• QTc interval

  Measurement of cardiac repolarization after albiglutide dosing

  6 weeks

Secondary Outcomes (3)

• QTc interval

  Day 4

• QT interval

  Day -1 and Day 40

• Number of participants with adverse events

  6 weeks

Study Arms (2)

Albiglutide + moxifloxacin placebo

ACTIVE COMPARATOR

Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40

Biological: Albiglutide

Albiglutide matching placebo + moxifloxacin

ACTIVE COMPARATOR

Once weekly subcutaneous injection of albiglutide matching placebo for 6 weeks, given with oral 400mg moxifloxacin tablet on Day -1 and moxifloxacin matching placebo on Day 40, or weekly albiglutide matching placebo for 6 weeks plus oral moxifloxacin matching placebo on Day -1 then oral 400mg moxifloxacin on Day 40

Drug: Moxifloxacin

Interventions

Albiglutide BIOLOGICAL

once weekly subcutaneous injection

Albiglutide + moxifloxacin placebo

Moxifloxacin DRUG

oral tablet

Albiglutide matching placebo + moxifloxacin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or nonpregnant, nonlactating female
• Subject considered to be in good health as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values
• BMI is ≥18 kg/m2 and ≤30 kg/m2
• Nonsmoker

You may not qualify if:

• Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
• History of arrythmia or use of antiarrhythmic agents
• History of any anaphylactic reaction to any drug
• History of significant cardiovascular or pulmonary dysfunction
• Current or chronic history of liver disease , renal disease, CNS disorders, thyroid dysfunction, rheumatoid arthritis
• History of alcohol or substance abuse
• History of GI surgery that could influence gastric emptying
• Female and using oral contraception (combined or progestogen only), implants or levonorgestrel, or injectable progesterone, or hormone replacement therapy
• History of pancreatitis

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

  PMID: 25387217 DERIVED

Related Links

• Results for study 107085 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

rGLP-1 protein; Moxifloxacin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 1, 2011
• Study Start: July 6, 2011
• Primary Completion: December 29, 2011
• Study Completion: December 29, 2011
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share